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Keeping you afloat amidst the rising sea of regulations

The Secret's Out: FDA Allows Drug and Device Manufacturers to Share HCEI Prior to Product Approval

Last week, FDA issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers, describing the Agency’s expectations for drug and device manufacturers’ communication of health care economic information (HCEI) about their products t

Changes to Iran Sanctions Regulations Means Good News for US Medical Device Manufacturers

OFAC Expands General Licenses to Export Medical Devices, and Associated Services, to Iran; OFAC Also Redefines “Iranian-Origin” Goods Eliminating Its Unintended Capture of Goods Just Passing Through Iranian Ports and Airports 

Senator Boxer Questions Medical Device Makers about Cybersecurity

On February 4, 2016, Senator Barbara Boxer (D-CA) sent a letter to the five largest medical device makers asking them to explain what steps they are taking to address cyber vulnerabilities in their products. The letter was sent to the chief executive officers of Johnson & Johnson, Medronic, GE Healthcare, Phillips North America, and Siemens USA.  

Lumos Labs Settles With FTC Over Brain Training Program Claims

The Federal Trade Commission announced this week that Lumos Labs had agreed to settle false and deceptive advertising claims related to the company’s promotion of its “Lumosity” cognitive training programs (commonly referred to as “brain training”).

The Internal Threat: Cyber Security and Medical Devices

A recent blog post in the IEEE Spectrum, “Hackers Invade Hospital Networks Through Insecure Medical Equipment,” focused attention on something known for a while: medical devices can open a door to hospital networks, wreaking all sorts of havoc.

eHealth – FTC Study Weighs in on Privacy and Security Concerns with its ‘Internet of Things’ Report

One of the more exciting and innovating changes to health care lies in the development of devices that expand the ability of patients to better manage their health and communicate with care providers who can monitor and potentially diagnose and treat patients remotely with the aide of special devices. Those devices which allow automated communications between machines are considered part of the Internet of Things (IoT), which was the subject of a report just released by the Federal Trade Commission (FTC).